Darzalex-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Beerse: Janssen-Cilag International NV, a Johnson & Johnson company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for DARZALEX (daratumumab) subcutaneous (SC) formulation. The recommendation is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd), for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). SC formulation was previously approved by the European Commission in June 2020.
“Optimising frontline therapy is crucial in disease control and improving long-term outcomes for patients with newly diagnosed multiple myeloma,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Johnson & Johnson Innovative Medicine. “By incorporating daratumumab SC into this novel quadruplet regimen, we aim to establish a new standard of care for eligible patients, enhancing progression-free survival and transforming the treatment landscape.”
The CHMP recommendation for daratumumab is supported by data from the Phase 3 PERSEUS (NCT03710603) study, evaluating D-VRd induction and consolidation therapy, and daratumumab with lenalidomide (D-R) maintenance therapy, compared to VRd induction and consolidation, and R maintenance, in transplant eligible patients with newly diagnosed multiple myeloma. Data from the study were recently presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
“Since its initial European approval in 2016, daratumumab has become a foundational therapy for the treatment of multiple myeloma, and we have remained dedicated to harnessing its full potential for all patients at every stage of the disease,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. “Today’s positive recommendation reflects our unwavering commitment to advancing novel therapies and transformative combination regimens, like D-VRd, towards the ultimate goal of eliminating this complex disease.”
Daratumumab is currently approved in eight indications for multiple myeloma, four of which are in the frontline setting, including as part of treatment regimens for newly diagnosed patients who are transplant-eligible or ineligible for ASCT.
The positive CHMP opinion follows the recent U.S. Food and Drug Administration (FDA) approval of daratumumab SC in combination with D-VRd for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for ASCT.
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